Status:
TERMINATED
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
Lead Sponsor:
Korea United Pharm. Inc.
Conditions:
Acute Sinusitis
Eligibility:
All Genders
12-75 years
Phase:
PHASE4
Brief Summary
This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients
Detailed Description
Patients with acute sinusitis were randomly assigned (1:1) to receive either cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group) and corresponding placebo...
Eligibility Criteria
Inclusion
- Patients diagnosed with sinusitis (accompanied with otitis media) at screening, and whose first symptoms occurred within the past 3 weeks
- Symptoms or signs of acute sinusitis persist without improvement for 10 days after onset or symptoms or signs of acute sinusitis initially improve and then worsen within 10 days
Exclusion
- Those who have a history of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics
- Those with a history of allergic rhinitis or other rhinitis
- Those who have been diagnosed with sinusitis more than 3 times within a year
- Have had or scheduled sinus surgery within 1 month
- Creatinine Clearance \< 40 mL/min at screening
- Those whose AST, ALT, and total bilirubin are more than 3 times the upper limit of normal at screening
- Cystic fibrosis patients
Key Trial Info
Start Date :
August 31 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT04664803
Start Date
August 31 2015
End Date
August 31 2019
Last Update
December 11 2020
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